Production Part Approval Process (PPAP)

Production Part Approval Process (PPAP)

What is PPAP? Production Part Approval Process
Standard used to formally reduce risks prior to product or service release, in a team oriented manner using well established tools and techniques Initially developed by AIAG (Auto Industry Action Group) in 1993 with input from the Big 3 - Ford, Chrysler, and GM AIAG’s 4th edition effective June 1, 2006 is the most recent version PPAP has now spread to many different industries beyond automotive

PPAP manages change and ensures product conformance!
Purpose of PPAP Provide evidence that all customer engineering design record and specification requirements are properly understood by the organization To demonstrate that the manufacturing process has the potential to produce product that consistently meets all requirements during an actual production run at the quoted production rate PPAP manages change and ensures product conformance!

PPAP is required with any significant change to product or process!
When is PPAP Required? New part Engineering change(s) Tooling: transfer, replacement, refurbishment, or additional Correction of discrepancy Tooling inactive > one year Change to optional construction or material Sub-supplier or material source change Change in part processing Parts produced at a new or additional location PPAP is required with any significant change to product or process!

Benefits of PPAP Submissions
Helps to maintain design integrity Identifies issues early for resolution Reduces warranty charges and prevents cost of poor quality Assists with managing supplier changes Prevents use of unapproved and nonconforming parts Identifies suppliers that need more development Improves the overall quality of the product & customer satisfaction

Production Run PPAP data must be submitted from a production run using: Production equipment and tooling Production employees Production rate Production process All data reflects the actual production process to be used at start-up!

Rate The purpose of a Rate is to verify the supplier’s manufacturing process is capable of producing components that meet NCR’s quality requirements, at quoted tooling capacity, for a specified period of time Verification of the Rate will be at the Supplier Quality Engineer’s (SQE) discretion. The supplier will be notified of the need to perform a Rate as early in the process as possible. The number of components to be produced during the Rate should be sufficient to demonstrate process capability and will be predetermined by the SQE and the supplier. Factors such as product complexity, shelf life, storage, cost and single shift vs. multiple shift operations will be taken into consideration

Official PPAP Requirements
Design Records Authorized Engineering Change Documents Customer Engineering Approval, if required Design Failure Modes and Effects Analysis (DFMEA) applied in special situations Process Flow Diagram Process Failure Modes and Effects Analysis (PFMEA) Control Plan Measurement Systems Analysis (MSA) Dimensional Results Records of Material / Performance Test Results Initial Process Studies Qualified Laboratory Documentation Appearance Approval Report (AAR) Sample Production Parts Master Sample Checking Aids Customer-Specific Requirements Part Submission Warrant (PSW) Now, let’s take a closer look at NCR’s requirements

NCR’s PPAP Requirements
Design Records Authorized Engineering Change Documents Customer Engineering Approval, if required Design Failure Modes and Effects Analysis (DFMEA) applied in special situations Process Flow Diagram Process Failure Modes and Effects Analysis (PFMEA) Control Plan Measurement Systems Analysis (MSA) Dimensional Results Records of Material / Performance Test Results Initial Process Studies Qualified Laboratory Documentation Appearance Approval Report (AAR) Sample Production Parts Master Sample Checking Aids Customer-Specific Requirements Part Submission Warrant (PSW) – NCR calls this the “Production Warrant” Supplier shall submit these 12 items and retain a copy of records at appropriate locations

NCR’s PPAP Requirements
Design Records Authorized Engineering Change Documents Customer Engineering Approval, if required Design Failure Modes and Effects Analysis (DFMEA) applied in special situations Process Flow Diagram Process Failure Modes and Effects Analysis (PFMEA) Control Plan Measurement Systems Analysis (MSA) Dimensional Results Records of Material / Performance Test Results Initial Process Studies Qualified Laboratory Documentation Appearance Approval Report (AAR) Sample Production Parts Master Sample Checking Aids Customer-Specific Requirements Part Submission Warrant (PSW) – NCR calls this the “Production Warrant” Supplier shall retain these 6 items at appropriate locations, and make readily available upon request

PPAP Submission Levels
Production Warrant and Appearance Approval Report (if applicable) submitted to NCR Level 2 Production Warrant, product samples, and dimensional results submitted to NCR Level 3 Production Warrant, product samples, and complete supporting data submitted to NCR Level 4 Production Warrant and other requirements as defined by NCR Level 5 Production Warrant, product samples and complete supporting data (a review will be conducted at the supplier's manufacturing location)

PPAP Submission Level Table
* = Supplier shall retain at appropriate locations, and submit to NCR upon request. NCR will identify what is needed for submission. S = Supplier shall submit to NCR & retain a copy of records or documentation items at appropriate locations R = Supplier shall retain at appropriate locations and make readily available to NCR upon request

Definition of Risk High Risk Medium Risk Low Risk
Parts associated with multiple critical features, complex design, or high end technology that is not yet established in the general manufacturing environment Supplier’s quality system and/or quality performance is not to NCR satisfaction Medium Risk Parts that have at least one critical feature Low Risk Parts that have no critical features and can be manufactured by any manufacturer in the commodity category Supplier’s quality system and quality performance are acceptable

Submission Level Requirements
New Parts Level 2 is required for Low Risk Parts Level 3 is required for Medium and High Risk Parts Part Changes Level 3 is required for Parts produced at a new or additional location Supplier Quality Excellence will define the level required for all other changes NCR reserves the right to redefine the submission level required

PPAP Status Approved Interim Approval Rejected
The part meets all NCR requirements Supplier is authorized to ship production quantities of the part Interim Approval Permits shipment of part on a limited time or piece quantity basis Rejected The part does not meet NCR requirements, based on the production lot from which it was taken and/or accompanying documentation Production quantities may not be shipped before NCR Approval

Electronic Submission Requirements
NCR requires that all PPAPs be submitted electronically Use of paper submission must have prior approval by the SQE Submission must be received on or prior to the PPAP due date Review and Approval Process: NCR will attempt to review and provide feedback within 2 business days NCR requires all submissions to be electronic

NCR PPAP Playbook What is the NCR PPAP Playbook?
An Excel spreadsheet containing templates of the documents suppliers are required to submit to NCR Why use the PPAP Playbook? Simplifies the process for suppliers by serving as a “checklist” of what needs to be submitted to NCR Reduces the number of files to manage Enables the SQE to quickly see if anything is missing Show PPAP Playbook

PRODUCTION WARRANT

Production Warrant What is It? Objective or Purpose When to Use It
Document required for all newly tooled or revised products in which the supplier confirms that inspections and tests on production parts show conformance to NCR requirements Used to : document part approval provide key information declare that the parts meet specification Objective or Purpose When to Use It Prior to shipping production parts Now, let’s take a closer look

Production Warrant Part Name / NCR Part Number
Engineering released finished end item part name and number Shown on Drawing Number The design record that specifies the customer part number being submitted Engineering Change Level & Date Show the change level and date of the Design Record Supplier Part Number Part number defined by the supplier, if any Additional Engineering Changes List all authorized Engineering changes not yet incorporated in the design record but which are incorporated in the part Safety and/or Government Regulation “Yes” if so indicated by the Design Record, otherwise “No” Purchase Order Number Enter this number as found on the contract / purchase order Checking Aid Number, Change Level, & Date Enter if requested by the customer

Production Warrant Supplier Manufacturing Information
Show the name and code assigned to the manufacturing site on the purchase order / contract Parts Identified with Appropriate Marking Codes UL = Underwriters Laboratories safety standards CE = Conformite Europeenne (European Conformity) – Certifies that a product has met European consumer Safety, health, or environmental requirements ISO = International Organization for Standardization Enter “Yes” or “No” NCR Location Show the location where parts will be shipped to Restricted Substances Enter “Yes” or “No” Buyer / Buyer Code Enter the buyer’s name and code Model Name / Number Enter the model name and number

Production Warrant Reason For Submission Check the appropriate box(es)
Requested Submission Level Identify the submission level requested by NCR Mold / Cavity / Production Process If production parts will be produced from more than one mold, cavity, tool, die, pattern, or production process, the supplier shall complete a dimensional evaluation on one part from each. The specific molds, lines, etc. shall then be identified here. Submission Results Check the appropriate boxes

Production Warrant Declaration Enter the number of pieces manufactured during the significant production run and the time (in hours) taken for the significant production run Declaration Affirmation that the samples represented by the warrant are representative and were made by a process that meets NCR’s PPAP requirements Explanation / Comments Provide any explanatory comments on the submission results or any deviations from the Declaration. Attach additional information as appropriate. Supplier Authorized Signature A responsible supplier official, after verifying that the results show conformance to all NCR requirements and that all required documentation is available, shall approve the declaration For NCR Use Only To be completed by appropriate NCR Supplier Quality Engineer PPAP Warrant Disposition Approved, Rejected, Other NCR Signature Signed by NCR Supplier Quality Engineer The approved Production Warrant officially warrants the parts ready for production

Production Warrant Reviewers Checklist Must be completely filled out
Must be signed by the supplier P/N must match the PO Submitted at the correct revision level Submitted at the correct submission level Specify the reason for submission

AUTHORIZED ENGINEERING CHANGE DOCUMENTS

Authorized Engineering Change Documents
The supplier shall provide authorized change documents for those changes not yet recorded in the design record, but incorporated in the product, part or tooling, such as: ECNs (must be approved, not pending) Specifications Feasibility studies Supplier change requests Sub-assembly drawings Life or reliability testing requirements

PROCESS FLOW DIAGRAM

Process Flow Diagram What is It? Objective or Purpose When to Use It
A visual diagram of the entire process from receiving through shipping, including outside processes and services To help people “see” the real process. Process maps can be used to understand the following characteristics of a process: Set-by-step process linkage Offline activities (measurement, inspection, handling) Rework, scrap Objective or Purpose When to Use It To understand how a process is done Prior to completing the PFMEA

Process Flow Diagrams The process flow diagram utilizes these symbols to clearly identify each step in the process

Process Flow Diagram - Example

Star Exercise Divide into teams Distribute supplies
Paper for Stars Instructions for making Stars Scissors Using the instructions handed out in class, make 10 Shuriken Stars This exercise will prepare your team to complete future exercises 45 Minutes

Process Flow Diagram – Star Exercise
Paper Folding Incoming Inspection Star Folding Final Inspection Cutting Tucking 10 15 20 05 25 30 Patrol Insp Report Shipping Packing 40 35 If rework possible Rework Inspection as per Operation layout 100% Inspection OK Not OK Scrap Next Operation

Process Flow Diagrams Reviewers Checklist
Process Flow must identify each step in the process Should include abnormal handling processes Scrap Rework Process Flow must include all phases of the process Receiving of raw material Part manufacturing Offline inspections and checks Assembly Shipping

PROCESS FMEA

The PFMEA should be completed using a cross-functional team!
Process FMEA (PFMEA) What is It? A tool used to identify and prioritize risk areas and their mitigation plans. Objective or Purpose Identifies potential failure modes, causes, and effects. Inputs come from the process flow diagram. Identifies key inputs which positively or negatively affect quality, reliability and safety of a product or process. When to Use It After completion of the process flow diagram. Prior to tooling for production IMPORTANT! The PFMEA should be completed using a cross-functional team!

FMEA Origin Created by NASA following Apollo 1 mission failure
Allows us to take a proactive approach to what can go wrong in a process and manage our risks better

This is included in the PPAP Playbook!
Process FMEA (PFMEA) This is included in the PPAP Playbook!

PFMEA - Step 1 Failure Modes For each Process Input, determine the ways in which the input can go wrong. Using the completed Process Flow Diagram, enter the process step. TIPS There should be at least one failure mode for each input.

PFMEA - Step 2 Potential Failure Effects For each Failure Mode, determine what effect the specific failure could have on the process output. TIPS There should be at least one failure effect for each failure mode. Effects should be specific, clear, and leave no doubt to the uninformed reviewer.

PFMEA - Step 3 Potential Causes For each Failure Mode, determine the possible cause of the failure. TIPS There should be at least one potential cause for each failure mode.

PFMEA - Step 4 Current Controls For each potential cause, list the current method used for preventing or detecting failure. TIPS This step in the FMEA begins to identify initial shortcomings or gaps in the current control plan. If a procedure exists, enter the document number. If no current control exists, list as “none.”

Severity, Occurrence and Detection rating details on next slide
PFMEA - Step 5 Assign Severity, Occurrence, and Detection ratings Assign Severity (How serious is the effect if it fails?) Assign Detection (How easily can the cause or failure mode be detected?) Assign Occurrence (How likely is the cause to occur?) Severity, Occurrence and Detection rating details on next slide

PFMEA - Definition of Terms
Severity (of Effect) - severity of the effect on the Customer and other stakeholders (Higher Value = Higher Severity) Occurrence (of Cause) - frequency with which a given Cause occurs and creates Failure Mode. (Higher Value = Higher Probability of Occurrence) Detection (Capability of Current Controls) - ability of current control scheme to detect the cause before creating the failure mode and/or the failure mode before suffering the effect (Higher Value = Lower Ability to Detect) Caution: Notice the scale difference for Detection!

An Example of Rating Definitions
Severity Occurrence Detection* Hazardous without warning Very high and almost inevitable Cannot detect or detection with very low probability Loss of primary function High repeated failures Remote or low chance of detection Loss of secondary function Moderate failures Low detection probability Minor defect Occasional failures Moderate detection probability No effect Failure unlikely Almost certain detection Rating High 10 Low 1 *If No Controls Exist, Detection = 10 Create a rating system that makes sense for the defects you are trying to prevent.

PFMEA - Step 6 Calculate the Risk Priority Number RPN = Severity x Occurrence x Detection TIPS The RPN is used to prioritize the most critical risks identified in the first half of the FMEA. High RPNs (125 or above) are flags to take effort to reduce the calculated risk. Regardless of RPN, high Severity scores (9 or 10) should be given special attention.

Analyzing the PFMEA Once the RPN Numbers are determined, they can be used to prioritize the most significant failure modes. Sort the FMEA by the RPN numbers. Graphical and statistical tools can help the team select a “cut-off” RPN for the next steps. Sort by RPN to determine the most significant failure modes ? How many items should be the focus of the next steps? RPN Thresholds When using an RPN threshold, DO NOT forget to address high Severity scores Pareto Chart

PFMEA – Remediation Guidelines
Severity – can only be improved by a design change to the product or process Occurrence – can only be reduced by a change which removes or controls a cause. Examples are redundancy, substituting a more reliable component or function or mistake-proofing. Detection – can be reduced by improving detection. Examples are mistake-proofing, simplification and statistically sound monitoring. In general, reducing the Occurrence is preferable to improving the Detection

FMEA – Step 7 Determine Actions Recommended to reduce High RPNs
For the high RPN numbers, determine the recommended actions.

FMEA – Steps 8 and 9 Now recalculate your RPNs
Resp (responsibility) Assign a specific person who will be responsible for recommended actions. Actions Taken As actions are identified and completed, document in the “Actions Taken” column. SEV, OCC, DET, RPN As actions are complete reassess Severity, Occurrence, and Detection and recalculate RPN. Now recalculate your RPNs based on mitigation plans. TIPS: Continue updating the actions taken and resulting RPNs until all risks are at an acceptable level (below 125).

Summary Steps To Complete a FMEA
For each Process Input, determine the ways in which the Process Step can go wrong (these are Failure Modes). For each Failure Mode associated with the inputs, determine Effects on the outputs. Identify potential Causes of each Failure Mode. List the Current Controls for each Cause. Assign Severity, Occurrence and Detection ratings after creating a ratings key appropriate for your project. Calculate RPN. Determine Recommended Actions to reduce High RPNs. Take appropriate Actions and Document. Recalculate RPNs. Revisit steps 7 and 8 until all the significant RPNs have been addressed.

Use the file PPAP Training Templates.xls
PFMEA Exercise Instructions Open the PPAP Training Templates.xls file, then select the PFMEA worksheet. Using process steps 20 and 25 from the completed Star Process Flow Diagram handout, complete 2 rows of the PFMEA. 30 Minutes Use the file PPAP Training Templates.xls

Tips and Lessons Learned
Process FMEA (PFMEA) Tips and Lessons Learned Collaborative Effort: Do not try alone, use a group Very laborious: Time consuming process. Take necessary breaks. Action items are required for completion Train team ahead of time by explaining scoring criteria Proper preparation is needed for meetings Summarize often: FMEA is a living document

Process FMEA (PFMEA) Reviewers Checklist
Verify there is a system for prioritizing risk of failure such as RPN numbers of 125 or above Make sure that high RPN process concerns are carried over into the control plan Make sure that all critical failure modes are addressed Safety Form, fit, function Material concerns

CONTROL PLAN

Control Plan What is It? Objective or Purpose NOTE When to Use It
A document that describes how to control the critical inputs to continue to meet customer expectations of the output. What is It? Objective or Purpose Primary reference source for minimizing process and product variation. Description of how teams should react to out-of-control situations. NOTE Since processes are expected to be continuously updated and improved, the control plan is a living document! When to Use It Implementation of new process Following a process change

New/Revised Process Steps
Control Plan Tool Interaction Process Steps Process Flowchart Process FMEA New/Revised Process Steps Risk Prioritized Process Steps Process Steps Control Plan Improved Controls New/Revised Process Steps

This is included in the PPAP Playbook!
NCR’s Control Plan This is included in the PPAP Playbook!

Control Plan 3 Distinct Phases 3 Distinct Phases
Prototype – a description of the dimensional measurements and material and performance tests that will occur during Prototype build. 3 Distinct Phases 2. Pre-Launch – a description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production. 3 Distinct Phases 3. Production – a comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production

Administrative Section
Control Plan Administrative Section Administrative Section Identifies part number and description, supplier, required approval signatures, and dates.

Control Plan Process, Machine/Tools, Characteristics Characteristics
Define the characteristics of the product or process Part/Process Use this area to define part/process number and description. Machine/Tools List the machine, device, jig, or tools that will be used in the manufacturing process

Control Plan Specifications, Measurement, Sample Size & Frequency
What is the size of the sample you should gather data from? Specifications/Tolerance Use this area to define upper/lower spec limits for each control element. Measurement Technique For each line in the control plan, list the measurement procedure that will be used (may list R&R Gage Plan or Poka-Yoke). Frequency Define the frequency for which the measurement will be taken.

Control Plan Control Method, Reaction Plan Control Method
Method that will be used to control the process Reaction Plan Actions to be taken if controls fail

Control Plan Audit Plans
Audit plans should be included in the control plan as a separate line. Auditing is an important tool for control. Process auditing should be a key element of the quality system of a business. Audits generally cover: Effectiveness of controls Control plan (say) vs. what is actually done (do) Audits should be objective (done by internal or external third parties if possible). Audit frequencies should be based on balancing level of risk (FMEA) and cost.

Control Plan – Example Sample Size Control Method Frequency
A supplier manufactures a circuit board with electronic components soldered on the board. Properly soldered connections are the major product characteristics. Two major process characteristics for the wave solder machine are solder level and flux concentration. An automated feeder controls the solder level by sensing the level of solder and feeding in additional solder as the level is reduced. This characteristic is measured 100% by checking electrically for continuity. The flux must be sampled and tested for the concentration level. Sample Size Product = 100% Process = 1 pc Control Method Product = Automated inspection Process = x-MR chart Frequency Product = Continuous Process = 4 hours Characteristics Product = Wave solder height Process = Flux concentration Part/Process Soldering Connections Machine/Tools Wave solder machine Reaction Plan Product = Adjust and retest Process = Segregate and retest Specifications/Tolerance Product = 2.0 +/ mc Process = Standard #302B 3 Distinct Phases Production Measurement Technique Product = Sensor continuity check Process = Test sampling lab environment

Control Plan Exercise Instructions Open the PPAP Training Templates.xls file, then select the Control Plan worksheet. Using the completed Star Process Flow Diagram (process steps 20 and 25) and the completed PFMEA, complete 2 rows of the Control Plan. Document potential problems that might be encountered and potential solutions with your teams. 20 Minutes Use the file PPAP Training Templates.xls

Control Plan Reviewer’s Checklist
Use process flow diagram and PFMEA to build the control plan; keep them aligned Controls must be used to be effective. Keep it simple. Ensure that the control plan is in the document control system of the business Good control plans address: All testing requirements - dimensional, material, and performance All product and process characteristics at every step throughout the process The control method should be based on an effective analysis of the process Such as SPC, Error Proofing, Inspection, Sampling Plan Control plans should reference other documentation Specifications, tooling, etc.

MEASUREMENT SYSTEM ANALYSIS (MSA)

Measurement System Analysis (MSA)
An MSA is a statistical tool used to determine if a measurement system is capable of precise measurement. What is It? Objective or Purpose To determine how much error is in the measurement due to the measurement process itself. Quantifies the variability added by the measurement system. Applicable to attribute data and variable data. When to Use It On the critical inputs and outputs prior to collecting data for analysis. For any new or modified process in order to ensure the quality of the data. Measurement System Analysis is an analysis of the measurement process, not an analysis of the people!! IMPORTANT! Who Should be Involved Everyone that measures and makes decisions about these measurements should be involved in the MSA.

Attribute and Variable MSA
Attribute Data Examples: Count, Pass/fail, yes/no, red/green/yellow, timekeeping buckets Variable Data Examples: Physical measurement (length, width, area, …) Physical conditions (temperature, pressure…) Physical properties (strength, load, strain…) Continuous or non-ending Unless approved by an NCR SQE, attribute data is not acceptable for PPAP submission

Variation The observed variation in process output measurements is not simply the variation in the process itself; it is the variation in the process plus the variation in measurement that results from an inadequate measurement system. Observed Variation Process Variation Conducting an MSA reduces the likelihood of passing a bad part or rejecting a good part

Observed Variation Measurement System Variation Observed Variation The output of the process measured by: Cycle time Dimensional data Number of defects and others Process Variation

Calibration addresses accuracy
Measurement System Analysis (MSA) Observed Variation Resolution Precision (Variability) Repeatability Reproducibility Measurement System Variation Linearity Accuracy (Central Location) Observed Variation Bias Stability Process Variation Calibration addresses accuracy

Calibration Addresses Accuracy
Measurement System Analysis (MSA) Observed Variation Resolution Precision (Variability) Repeatability Reproducibility Measurement System Variation Linearity Accuracy (Central Location) Observed Variation Bias Stability Process Variation Calibration Addresses Accuracy Let’s take a closer look at Precision

Resolution Error in Resolution The inability to detect small changes. Possible Cause Wrong measurement device selected - divisions on scale not fine enough to detect changes.

Repeatability Error in Repeatability The inability to get the same answer from repeated measurements made of the same item under absolutely identical conditions. Possible Cause Lack of standard operating procedures (SOP), lack of training, measuring system variablilty. Equipment Variation

Reproducibility Error in Reproducibility The inability to get the same answer from repeated measurements made under various conditions from different inspectors. Possible Cause Lack of SOP, lack of training. Appraiser Variation

Variable MSA – Gage R&R Study
Gage R&R is the combined estimate of measurement system Repeatability and Reproducibility Typically, a 3-person study is performed Each person randomly measures 10 marked parts per trial Each person can perform up to 3 trials There are 3 key indicators EV or Equipment Variation AV or Appraiser Variation Overall % GRR

Variable MSA – NCR’s Gage R&R Form
Automatically calculates EV, AV, and % GRR! Included in PPAP Playbook!

Variable MSA – Gage R&R Steps
Select 10 items that represent the full range of long-term process variation. Identify the appraisers. If appropriate, calibrate the gage or verify that the last calibration date is valid. Open the Gage R&R worksheet in the PPAP Playbook to record data. Have each appraiser assess each part 3 times (trials – first in order, second in reverse order, third random). Input data into the Gage R&R worksheet. Enter the number of operators, trials, samples and specification limits Analyze data in the Gage R&R worksheet. Assess MSA trust level. Take actions for improvement if necessary.

Steps 1 and 2: Variable MSA - Gage R&R
Select 10 items that represent the full range of long-term process variation. Step 1 Step 2 Identify the appraisers. Should use individuals that actually do the process being tested. Can also include other appraisers (supervisors, etc.). Should have a minimum of 3 appraisers.

Steps 3 and 4: Variable MSA – Gage R&R
If appropriate, calibrate the gage or verify that the last calibration date is valid. Step 3 Step 4 Open the Gage R&R worksheet in the PPAP Playbook to record the data

Step 5: Variable MSA – Gage R&R
Have each appraiser assess each item 3 times. Each appraiser has to work independently. Items should be evaluated in random order. After each appraiser completes the first evaluation of all items – repeat the process at least 2 more times. Do not let the appraisers see any of the data during the test !!

Input data into the Gage R&R worksheet Step 7 Enter the number of operators, trials, samples and specification limits

Analyze data in the Gage R&R worksheet Step 9 Assess MSA Trust Level. Red: > 30% (fail) Yellow: 10-30% (marginal) Green: < 10% (pass) % Tolerance* 10% 30%

Step 10: Variable MSA – Gage R&R
If the Measurement System needs improvement: Brainstorm with the team for improvement solutions. Determine best “practical solution” (may require some experimentation). Pilot the best solution (PDSA) Implement best solution – train employees. Re-run the study to verify the improvement.

Variable MSA – Gage R&R Example
Problem Statement The sulfuric acid concentration in process tank 8 is measured at least once per day Additions/deletions of chemicals and decisions to shut down the process are dependent on these results. Based on current data, we need to do an MSA. MSA Process A Gage R&R was conducted in order to validate the process. MSA Parameters (3) Operators (3) Trials (10) Samples

Entered upper and lower specification limits Entered the number of operators, trials, and samples Chose 3 operators to be appraisers Had each appraiser measure each sample 3 times Results calculated automatically Selected 10 samples to be measured

% Tolerance* 10% 30% Repeatability = (EV) Equipment Variation Reproducibility = (AV) Appraiser Variation Repeatability & Reproducibility = R&R % Tolerance is > 30% MSA fails!

Gage R&R Exercise - Setup Instructions
Divide into teams Distribute stars (10 per team), measurement devices (1 per team), and markers (1 per team). Number the stars from 1-10. Mark the 2 points to be measured on each star (see diagram on next page) Determine and document the measurement process. Be sure everyone has a clear understanding of the process. Determine roles. (3) inspectors, (1) data recorder, (1) customer

Gage R&R Exercise - Dimensional Information
Each star will be measured as shown. Mark the 2 points to be measured Dimension

Gage R&R Exercise – Inspection Instructions All inspectors need to wait outside the room when it is not their turn to evaluate the stars. Open the PPAP Training Templates.xls file, then select the Gage R&R worksheet to record the data. Round 1 Have the 1st inspector come in the room and measure all 10 stars in order. Data collector record the data in the Gage R&R worksheet. Do not give any additional information to the inspector Repeat Step 3 with the 2nd inspector Repeat Step 3 with the 3rd inspector Round 2 Change the inspection to reverse order and repeat. Round 3 Change the inspection to random order and repeat. Use the file PPAP Training Templates.xls

Gage R&R Exercise - Analysis Instructions Complete the top section of the Gage R&R worksheet Enter the number of operators, trials, and samples Enter the upper and lower specification limit Assess MSA Trust Level. Red: > 30% (fail) Yellow: 10-30% (marginal) Green: < 10% (pass) Interpret results - are improvements required? % Tolerance* 10% 30% 45 Minutes Use the file PPAP Training Templates.xls

Tips and Lessons Learned
Important: An MSA is an analysis of the process, not an analysis of the people. If an MSA fails, the process failed. A Variable MSA provides more analysis capability than an Attribute MSA. For this and other reasons, always use variable data if possible. The involvement of people is the key to success. Involve the people that actually work the process Involve the supervision Involve the suppliers and customers of the process An MSA primarily addresses precision with limited accuracy information.

MSA Reviewer’s Checklist
If the gage/inspection affects quality, then conduct a Gage R&R Make sure the study is recent - less than 1 year Compare the control plan gages against the Gage R&Rs If you question that gage, then Question the technique and part sampling Ask for additional studies

DIMENSIONAL RESULTS

Dimensional Results What is It? Objective or Purpose When to Use It
Evidence that dimensional verifications have been completed and results indicate compliance with specified requirements. What is It? Objective or Purpose To show conformance to the customer part print on dimensions and all other noted requirements. When to Use It For each unique manufacturing process (e.g., cells or production lines and all molds, patters, or dies

NCR Dimensional Report (Critical)
Automatically Calculates Cpk! Requires 35 data points Cpk must be greater than or equal to 1.67 This is included in the PPAP Playbook!

NCR Dimensional Report (Non-Critical)
Automatically Calculates Cpk! Requires 5 data points Cpk must be greater than or equal to 1.33 This is included in the PPAP Playbook!

Acceptance Criteria Acceptance criteria for critical vs. non-critical characteristics Critical Non-Critical Decision Red (Bad) <1.33 <1.00 Yellow (OK) Green (Good) >1.67 >1.33 Cpk must be greater than or equal to 1.67 for critical processes Cpk must be greater than or equal to 1.33 for non-critical processes

NCR Dimensional Report Example
Nominal Value Tolerance Sample Data Cp & Cpk Calculations Pass / Fail Cpk > 1.33 for all non-critical dimensions = Pass!

Dimensional Results Reviewer’s Checklist
Thirty-five critical data points & 5 non-critical data points are required for part qualification Critical and non-critical data points must be taken from the same 35-piece sample Five parts from a production run must be shipped to NCR for verification of form, fit, and function The same 5 parts will be used to verify both critical and non-critical dimensions Supplier must clearly identify which of the 35 parts are being shipped Supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for non-critical dimensions Capability must be greater than 1.67 for critical dimensions and greater than 1.33 for non-critical dimensions

RECORDS OF MATERIAL / PERFORMANCE TEST RESULTS

Records of Material/Performance Test Results
Material Test Results The supplier shall perform tests for all parts and product materials when chemical, physical, or metallurgical requirements are specified by the design record or Control Plan For products with NCR-developed material specifications and/or an NCR-approved supplier list, the supplier shall procure materials and/or services from suppliers on that list Performance Test Results The supplier shall perform tests for all parts or product materials when performance or functional requirements are specified by the design record or Control Plan

Material Results Material Results shall include:
The name of the laboratory that conducted the test The type of test that was conducted The number, date, and specification to which the part was tested The actual test results

Module Test Results Module Test Results shall include:
The name of the laboratory that conducted the test The type of test that was conducted A description of the test The parameters tested The actual test results

INITIAL PROCESS STUDY

Initial Process Study Even though Initial Process Study is coded as an “R” on the PPAP Submission Level Table, we felt it was important to provide a brief overview during training R = Supplier shall retain at appropriate locations, including manufacturing and make readily available to the customer representative upon request

Initial Process Study Capability Analysis What is It?
A set of tools used to understand process capability. Objective or Purpose To evaluate the performance of your process as compared to specification limits. To determine if the production process is likely to produce product that will meet customer requirements When to Use It 1. To establish baseline capability. 2. To validate process improvements.

Steps for Determining Process Capability
Decide on the product or process characteristic to be assessed Validate the specification limits Validate the measurement system Collect data Assess data characteristics Assess process stability Calculate process capability

Step 1: Which Characteristic
Decide on the product or process characteristic to be assessed. Required for all critical characteristics If no critical characteristics exist, NCR reserves the right to require demonstration of initial process capability on other characteristics

Step 2: Specification Limits
Validate the specification limits by talking to: Customers, suppliers, controlling agencies Why is validation of the specification limits important? They may not represent what the customer truly desires/needs. May contain “guard banding” as a result of past problems or measurement error. They may be based on previous designs and no longer be valid.

Step 3: Measurement System
Validate the measurement system through the appropriate MSA Why is validation of the Measurement System important? If there is significant error in your measurement system, then decisions are influenced by the error not just the measurements themselves.

Step 4: Data Collection When collecting data, consider the Step 4
following: Short term data Free of special causes Collected across a narrow inference space i.e. one shift, one machine, one operator, etc.. Long term data Subjected to the effects of both random and special cause variation Collected across a broad inference space i.e. multiple shifts, machines, operators, etc.

Step 4: Data Collection Step 4
When collecting data, consider the following: Rational sub-grouping A group of units produced under the same set of conditions Mean to represent a “snapshot” of the process Must be taken close together in time, but still be independent of each other Use subgroups to separate the 2 types of variation in a process: Within subgroup: The variation among measurements within subgroups; also known as common cause variation Between subgroup: variation between subgroups that may be caused by specific identifiable factors, or special causes To improve process quality, every effort should be made to eliminate between subgroup variation and reduce within subgroup variation Example: A die cut machine produces 100 plastic parts per hour. The quality engineer measures 5 randomly selected parts at the beginning of every hour. Each sample of 5 parts is a subgroup.

Step 5: Data Characteristics
Assess data characteristics Examine the shape of your data. Is it what you would expect? If not, investigate. Bimodal Data The shape of your data is important for determining which type of Capability Analysis applies. Normal Data Skewed Data

Step 6: Process Stability
Assess process stability in order to understand how your process behaves over time. Control charts are the recommended tool. Control Chart Examples Process is stable and in control Process is not stable and therefore not in control Capability is only valid when the process being studied is stable!

Step 7: Process Capability
Calculate the appropriate statistical metrics in order to determine how the “Voice of the Process” compares to the “Voice of the Customer.” Capability Metrics: PPM, DPMO, Cp, Cpk, Pp, & Ppk ; Sigma Levels (Z Scores) Specification Limits Specification Limits Process is capable Process is not capable If you were driving a truck, and the dotted lines were the construction barriers, what would be happening in each situation?

Focus on Variable Data The initial process study should be focused on variable, not attribute data Assembly errors, test failures, and surface defects are examples of attribute data, which is important to understand, but is not covered in this initial study To understand the performance of characteristics monitored by attribute data will require more data collected over time Unless approved by an authorized NCR representative, attribute data are not acceptable for PPAP submission Focus on variable data

Capability Indices Cp Cpk PP Ppk
Capability Index Formula What it shows Cp Relates short term (within subgroup) standard deviation to tolerance Sometimes called “Entitlement,” meaning it is the best the current process can do, if centered Cpk Relates short term mean & short term (within subgroup) standard deviation to tolerance Only tells you about the nearest spec limit; doesn’t tell anything about the other side PP Relates long term (overall) standard deviation to tolerance Ppk Relates mean & long term (overall) standard deviation to tolerance (USL – LSL) 6*sshort-term Cp/Cpk are used to estimate potential process capability Min{(USL – X), (X – LSL)} 3*sshort-term (USL – LSL) 6*slong-term Pp/Ppk are used to measure actual process performance 3*slong-term Min{(USL – X), (X – LSL)}

Capability Indices - Cpk
Cpk predicts capability Based on short term within subgroup variation Does not include the effect of process variability between subgroups Cpk should be used when: Developing new parts Revising specifications on a part Materials, processes, manufacturing location, or equipment have significantly changed Material suppliers have changed (include certificate of analysis)

Capability Indices - Ppk
Ppk indicates past performance Based on long term total variation Unlike Cpk, Ppk is not limited to variation within subgroups However, Ppk cannot isolate within subgroup variation from between subgroup variation When calculated from the same data set, Cpk and Ppk can be compared to analyze the sources of process variation Ppk should be used when: The supplier is new to NCR, but has already been manufacturing a part The supplier is existing, but has produced a number of nonconforming parts

Difference between Cp & Cpk
Cp – determines capability of producing to specification Cpk – same as Cp, but also measures how centered the process is It is important to look at both! LSL USL Cp > 1.67 Cpk LSL USL Cp > 1.67 Cpk < 1.00 Capable, Centered Capable, Not Centered LSL USL Cp < 1.00 LSL USL Cp < 1.00 Cpk < 1.00 Cpk < Not Capable, Centered Not Capable, Not Centered

Acceptance Criteria Acceptance criteria for critical vs. non-critical characteristics Critical Non-Critical Decision Red (Bad) <1.33 <1.00 Yellow (OK) Green (Good) >1.67 >1.33 Cpk must be greater than or equal to 1.67 for critical processes Cpk must be greater than or equal to 1.33 for non-critical processes

Initial Process Study Reviewer’s Checklist
Ensure that the results are acceptable, and that the process is stable and capable of producing a quality part PPAPs should only be approved if the capability is greater than 1.67 for critical dimensions and greater than 1.33 for non-critical dimensions More information about capability is available in the Appendix at the end of this presentation

QUALIFIED LABORATORY DOCUMENTATION

Qualified Laboratory Documentation
Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by NCR requirements (e.g., an accredited laboratory). The qualified laboratory (internal or external to the supplier) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted When an external laboratory is used, the supplier shall submit the test results on the laboratory letterhead or the normal laboratory report format The name of the laboratory that performed the tests, the date(s) of the tests, and the standards used to run the tests shall be identified.

APPEARANCE APPROVAL REPORT

Appearance Approval Report
What is It? A report completed by the supplier containing appearance and color criteria Objective or Purpose To demonstrate that the part has met the appearance requirements on the design record When to Use It Prior to tooling for production IMPORTANT! Typically only applies for parts with color, grain, or surface appearance requirements

Administrative Section Supplier Sourcing & Texture Information List all first surface tools, graining Source(s), grain type(s), and grain and Gloss masters used to check part Pre-Texture Evaluation To be completed by SQE

Master Number Enter alphanumeric master identification Master Date Enter the date on which the master was approved Material Type Identify first surface finish and substrate (e.g. paint / ABS) Material Source Identify first surface and substrate suppliers Color Shipping Suffix Color part number suffix or color number Color Suffix Alphanumeric or numeric color identification Tristimulus Data List numerical (colorimeter) data of submission part as compared to the customer-authorized master Part Disposition To be determined by NCR (approved or rejected) Hue, Value, Chroma, Gloss, and Metallic Brilliance Visual assessment by NCR

SAMPLE PRODUCTION PARTS

Sample Production Parts
Actual samples that reflect the parts documented in the PPAP. What is It? Objective or Purpose Confirm cosmetic or functional part approval. When to Use It Sample parts should be delivered WITH the PPAP submission

The sample parts provided should be the same parts measured for the dimensional results Default quantity for all submissions is 3 parts unless otherwise requested

Sample production parts MUST be properly identified Include the following information on the part label: Date parts were packed NCR part number Quantity Serial number Supplier part number (optional) Part description Country of origin Indication of RoHS compliance Approval markings (UL, CE, etc.) where applicable See NCR part label examples on the next slide

Part Label Example

PPAP Summary The Production Part Approval Process is an extensive approval process for new or changed designs or processes It is very formalized, so it inevitably causes some administrative work Later changes to the product or process can be expensive and time-consuming!

APPENDIX – CAPABILITY

Process Capability Tool Selection Map
Process Capability can be determined for all types of data. However, selecting the correct method is critical.

Index of Capability Examples (Using Minitab)
Capability – Normal Capability - Normal Capability – Non-Normal Distribution Identification Central Limit Theorem Box – Cox Transformation

Normal Capability Example
Activity Using the data in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Time to Process one individual PO Use the file Capability Example.MTW

Normal Capability Example
Q Which Capability Analysis applies? Is the data attribute or variable? Is the data normal? Does sub-grouping apply? Yes ??? A Normal

Normal Capability Analysis in Minitab
Open the worksheet Capability Example.MTW. Choose Stat > Quality Tools > Capability Analysis > Normal. Click in the [Single Column] field. Double click [Time to Process] in the column on the left. Click in the [Subgroup Size] field. Depending on subgroup information either: a. Enter 1 if the subgroup size is 1. b. Double click Indiv Dates_1 in the column on the left. c. Since the subgroup size is constant (n=5) the number 5 could be typed in the subgroup size field. Use the file Capability Example MTW

Normal Capability Analysis in Minitab
Type 20 in Lower Spec. Type 40 in Upper Spec. Select [Options] button. Add target value (if applicable). Under Display select Parts per million or Percents Capability Stats or Benchmark Z Add Title if desired. Click [OK].

Normal Capability Analysis Results
Sample Mean Voice of the Customer Voice of the Process StDev (Within): Represents short term data. StDev (Overall): Represents long term data, includes shift and drift between subgroups.

Normal Capability Analysis Results
Exp Within Performance: Based on StDev(Within) and represents short term process capability. Capability indices: Based on short term data. Exp Overall Performance: Based on StDev (Overall) and represents long term process capability. Capability indices: Based on long term data. Observed Performance: Represents the sample data.

Non-Normal Capability – Distribution Identification
Exercise Using the data (Time_2) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time that is required to process the POs. Time to Process one individual PO Use the file Capability Example. MTW

Non-Normal Capability – Distribution Identification
Q Which Capability Analysis applies? Is the data attribute or variable? Is the data normal? Are the reasons for non-normality understood? Can the data be described by another distribution? No Yes A ??? Non-normal Try Individual Distribution Identification

Individual Distribution Identification in Minitab
Open the worksheet Capability Example.MTW. Choose Stat > Quality Tools > Individual Distribution Identification. Click in the [Single Column] field. Double click Time_2 in the column on the left. Choose [Use all distributions]. Click [OK]. Use the file Capability Example. MTW

Individual Distribution Identification in Minitab

Using Individual Distribution Identification
Open the worksheet Capability Example.MTW. Choose Stat > Quality Tools > Capability Analysis > Nonnormal. Click in the [Single Column] field. Double click Time_2 in the column on the left. Select [Fit data with Distribution]. Using pulldown menu select [3-parameter Weibull]. Type 20 in [Lower Spec]. Type 40 in [Upper Spec]. Use the file Capability Example. MTW

Select [Options] button. Add target value (if applicable). Under Display select Capability Stats Benchmark Z Add Title if desired. Click [OK].

Overall Capability: Benchmark Z or Capability indices - based on long term data Sample Mean Voice of the Customer Voice of the Process Exp Overall Performance: Represents long term process capability Observed Performance: Represents the sample data

Non-Normal Capability – Central Limit Theorem
Activity Using the data (Time_3 and Time 3 sub) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Time to process one individual PO Average time to process five POs per day Use the file Capability Example. MTW

Non-Normal Capability – Central Limit Theorem
Q Which Capability Analysis applies? Is the data attribute or variable? Is the data normal? Are the reasons for non-normality understood? Can the data be described by another distribution? Can the data be sub-grouped? Is the sub-grouped data normal? No Yes No Yes A ??? Non-normal Try sub-grouping the data

Use the file Capability Example. MTW
Using Central Limit Theorem Sub-Grouping Caution! Check sub-group data Time_3 sub for normality. If the data is not normal then this method cannot be used! Open the worksheet Capability Example.MTW. Choose Stat > Quality Tools > Capability Analysis > Normal. Click in the [Single Column] field. Double click Time_3 in the column on the left. Click in the [Subgroup Size] field – Double click Individ Dates_3 in the column on the left. Type 20 in [Lower Spec]. Type 40 in [Upper Spec]. Important! The sub-groups have to make logical sense, such as by day, by shift, by machine… Use the file Capability Example. MTW

Using Central Limit Theorem Sub-Grouping
Select [Options] button. Add target value (if applicable). Under Display select Parts per million or Percents Capability Stats or Benchmark Z Add Title if desired. Click [OK].

Sample Mean Voice of the Customer Voice of the Process StDev (Within): Represents short term data StDev (Overall): Represents long term data, includes shift and drift between subgroups

Exp Within: Performance: Based on StDev(Within) and represents short term process capability Capability indices: Based on short term data. Exp Overall: Performance: Based on StDev(Overall) and represents long term process capability. Capability indices: Based on long term data. Observed Performance: Represents the sample data.

Non-Normal Capability – Box-Cox Transformation
Activity Using the data (Time_4) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Time to Process one individual PO

Non-Normal Capability – Box-Cox Transformation
Q Which Capability Analysis applies? Is the data attribute or variable? Is the data normal? Are the reasons for non-normality understood? Can the data be described by another distribution? Can the data be sub-grouped? Can data be transformed? No Yes No No A ??? Non-normal Try Box-Cox transformation

Box-Cox Transformation
Open the worksheet Capability Example.MTW Choose Stat > Control Charts > Box-Cox Transformation Choose [All Observations …in one column] from pull down menu Click in Large Box Double click [Time_4] in the column on the left Click in the [Subgroup Size] field – enter 1 Select [Options] radio button Select [Optimal Lambda] Enter column for Stored Data Click [OK]

Box-Cox Transformation Results
Transformed Data Lambda Values Q Is the transformed data normal?

Using Box-Cox Transformation
Open the worksheet Capability Example.MTW Choose Stat > Quality Tools > Capability Analysis > Normal Click in the [Single Column] field Double click Time_4 in the column on the left Use the original data, not the transformed data. Click in the [Subgroup Size] field – enter 1 (the data is already sub-grouped) Type 20 in Lower Spec Type 40 in Upper Spec Caution! Check transformed data for normality. If the data is not normal then this method cannot be used! Use the file Capability Example. MTW

Select [Box-Cox] radio button Select [Box-Cox power transformation] Select [Use Optional lambda] Click OK Select [Options] radio button Add target value (if applicable) Under Display select Parts per million or Percents Capability Stats or Benchmark Z Add Title if desired Click [OK]

Transformed Voice of the Customer
Using Box-Cox Transformation Original Distribution Calculated Lambda Original Sample Data Transformed Voice of the Customer Transformed Sample Data Transformed Voice of the Process

Exp Within Performance: Based on StDev (Within) and represents short term process capability. Capability indices: Based on short term data Exp Overall Performance: Based on StDev (Overall) and represents long term process capability. Capability indices: Based on long term data. Observed Performance: Represents the sample data

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